Submit The Documentation Specified Jobs

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Submit Docs Spec roles are booming as companies accelerate digital compliance and adopt AI‑powered submission tools. The shift toward cloud‑based eCTD portals and real‑time audit trails has created a surge in demand for specialists who can navigate evolving regulatory landscapes.

Positions range from Documentation Specialist and Regulatory Affairs Coordinator to Technical Writer and Compliance Analyst. Core duties include drafting and reviewing eCTD dossiers, maintaining ISO 9001 and ISO 13485 documentation in MasterControl or SharePoint, managing audit evidence, and liaising with regulatory agencies via portals such as FDA’s 21 CFR Part 11 or EMA’s portal.

Salary transparency in this niche is critical because it highlights the premium paid for expertise in GxP, data privacy, and audit readiness. Clear pay data empowers professionals to assess the true value of their certifications and seek roles that match their skill level.

Brand Technical Specialist– Entry Level Sales Program 2026

Company: IBM

Location: Multiple Cities

Posted Dec 09, 2025

IBM's Brand Technical Specialist role emphasizes collaboration, technical expertise, and career growth, offering opportunities to solve complex challenges and drive digital transformation.

Network Security Consultant - L3

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Location: Mumbai, IN

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Location: Kochi, IN

Posted Dec 09, 2025

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Location: Multiple Cities

Posted Dec 09, 2025

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Company: IBM

Location: BANGALORE, IN

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Company: IBM

Location: Krakow, PL

Posted Dec 09, 2025

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Company: IBM

Location: Multiple Cities

Posted Dec 09, 2025

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Company: IBM

Location: Multiple Cities

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Entry Level Product Manager: 2026

Company: IBM

Location: Multiple Cities

Posted Dec 09, 2025

This text outlines the role of a Product Manager in AI and data-centric offerings, emphasizing collaboration across teams, ethical AI practices, and data-driven strategies to deliver innovative solutions. It highlights required skills in agile methodologies, product analytics, and cross-functional stakeholder alignment.

Associate Application Consultant Co-op 2026

Company: IBM

Location: No City, US

Posted Dec 09, 2025

This text promotes IBM Consulting's career opportunities, emphasizing collaboration with global clients, professional growth, and impactful work in hybrid cloud and AI. It highlights skill development, mentorship, and potential for full-time roles, while outlining required and preferred qualifications for the position.

BPOプロジェクトチームリーダー(経理財務)

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Location: Naha, JP

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This job description outlines financial and administrative support roles with opportunities for teamwork, management growth, and cross-cultural experience. The position involves systematic tasks like accounting processing, Excel-based reporting, and workflow system management, with structured schedules and collaborative environments.

Cloud Platform Software Engineer - OpenSearch

Company: IBM

Location: Markham, CA

Posted Dec 09, 2025

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Frequently Asked Questions

What are typical salary ranges by seniority in Submit Docs Spec roles?
Entry‑level Documentation Specialists earn $55,000–$70,000 annually. Mid‑level Coordinators and Technical Writers command $75,000–$95,000, while senior Regulatory Affairs Managers and Compliance Directors often reach $110,000–$140,000, depending on industry and geographic location.
Which skills and certifications are required?
Key skills include eCTD submission, ISO 9001/13485 documentation, GxP audit readiness, MasterControl or Sparta compliance software, and strong technical writing. Certifications such as Certified Regulatory Affairs Professional (CRA), Certified Quality Auditor (CQA), ISO 9001 Lead Auditor, and Six Sigma Green/Black Belt give candidates a competitive edge.
Is remote work available for Submit Docs Spec positions?
Yes, many employers support fully remote or hybrid models for documentation specialists and regulatory coordinators. Remote roles often rely on secure cloud platforms (e.g., SharePoint, Confluence, MasterControl) and virtual audit tools to maintain compliance.
What career progression paths exist?
Typical progression starts with Documentation Specialist → Regulatory Affairs Coordinator → Technical Writer → Regulatory Affairs Manager → Director of Compliance or Regulatory Affairs. Advancement often requires additional certifications and proven success managing multi‑regulatory submissions.
What are current industry trends affecting Submit Docs Spec roles?
Trends include AI‑driven document review for faster submission cycles, blockchain for immutable audit trails, regulatory sandboxes for digital health and medical devices, and increased focus on data privacy regulations like GDPR and CCPA. Professionals who stay current with these technologies will command higher salaries.

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